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Immuron Limited

March 2018

Oral Immunoglobulins

Changing the Paradigms

of Care

www.immuron.com

ASX:IMC NASDAQ:IMRN

Forward Looking Statement

Certain statements made in this presentation are forward-looking statements

and are based on Immuron’s current expectations, estimates and projections.

Words such as “anticipates,” “expects,” “intends,” “plans,” “believes,” “seeks,”

“estimates,” “guidance” and similar expressions are intended to identify

forward-looking statements.

Although Immuron believes the forward-looking statements are based on

reasonable assumptions, they are subject to certain risks and uncertainties,

some of which are beyond Immuron’s control, including those risks or

uncertainties inherent in the process of both developing and commercializing

technology. As a result, actual results could materially differ from those

expressed or forecasted in the forward-looking statements.

The forward-looking statements made in this presentation relate only to events

as of the date on which the statements are made. Immuron will not undertake

any obligation to release publicly any revisions or updates to these forward-

looking statements to reflect events, circumstances or unanticipated events

occurring after the date of this presentation except as required by law or by

any appropriate regulatory authority.

Company Highlights

3

• Clinical stage biopharmaceutical company targeting inflammatory-mediated and infectious diseases with oral immunotherapies

• Validated technology platform – with one registered asset generating revenue

• 2 Lead clinical assets in Phase 2 development for the treatment of multiple high value indications, Fat Liver Disease and CDI.

• Excellent safety profile, GRAS by FDA, expedited regulatory review and approval process

• Well positioned to address high unmet medical need in multiple blockbuster markets

• High-value peer licensing deals and M&A underscore potential upside

• Company listed on NASDAQ in 2Q 2017

• Experienced Management Team and strong support from leading KOLs and institutions (NIH, DoD)

Platform Overview: Oral Immunoglobulins

4

1

Vaccines Are

Developed

2

Antibodies Are Harvested

from Colostrum

Antigen Specific

Antibodies

(IgG and IgG1)

Adjuvants+

3

Broad Therapeutic Effect

+

• Reduced gut and blood pathogens

responsible for initiating

inflammation

• Reduces systemic inflammation

• Lowers organ injury

• Strong anti-toxin properties

• Decrease toxin levels results in

decrease gut damage

• Generally Regarded as Safe

(GRAS)

Induction of

regulatory

T-cells

Clearance of

Targeted GUT

Pathogens

Competitive

Advantage

• Platform capable of producing multiple drug candidates Long-term value creation

• Bovine IgG possesses a unique ability to remain active in the human GI tract

delivering its full benefits to the bacteria found there

• Bovine IgG is capable of withstanding the acidic environment of the stomach and is

resistant to proteolysis by the digestive enzymes in the GI tract

• Safety established Not absorbed into the blood

Immuron’s Clinical Programs

Multiple Near-Term Inflection Points

5

Program IndicationsDevelopment Stage

Program HighlightsPre-Clinical Phase 1 Phase 2 Phase 3

Anti-Inflammatory Programs

IMM-124E NASH - Topline results Available

IMM-124E ASH- NIH Funded; UVA- Topline results expected 2019

IMM-124E Pediatric NAFLD- NIH Funded; Emory University- Topline results expected 4Q 2018

IMM-124E ColitisCollaboration with Dr. Rogler, Zurich University

IMM-124E AutismMurdoch Childrens Research Institue, La Trobe & RMIT Universities

Anti-Infective Programs

IMM-529 C. difficile- Phase 1/2 initiated 4Q 2017- Topline results expected Q4 2018

IMM-124E / Shigella Vaccine

Shigella Infections

Collaboration with US Army

IMM-124ECampylobacter; ETEC Infections

Collaboration with US Navy

• Hyperimmune bovine colostrum powder

200mg (30 caplets, 24 month shelf life)

• Reduces the risk of TD, reduces the

symptoms of minor GI disorders

TRAVELAN

6

Regulatory

Authority

Regulatory Pathway Indications

TGA Listed Medicine • Reduces the risk of travellers’ diarrhoea

• Reduces the symptoms of minor gastro-intestinal disorders

• Antimicrobial

Medsafe (New

Zealand)

Not marketed in New Zealand Not marketed in New Zealand

FDA (USA) Self-affirmed generally

regarded as safe (GRAS)

Dietary supplement. FDA does

not review dietary supplements

for safety and effectiveness

Hyperimmune colostrum dietary supplement

Health Canada Natural Health Product Travelan helps reduce the risk of traveller’s diarrhea.

EMA (Europe) Not marketed in Europe Not marketed in Europe

ARTG Listing for Travelan

http://www.travelanusa.com/

Australian Packaging

US Packaging

Prominent immune-reactive bands of

Campylobacter, ETEC and Shigella isolates

from Bhutan, Cambodia, Nepal and Thailand

7

Travelan immunoreactivity study:

• Armed Forces Research Institute of Medical Sciences (AFRIMS)

• Walter Reed Army Institute of Research (WRAIR)

• US Naval Medical Research Centre (NMRC)

Immuron Limited

March 2018

IMM-124E-2001 NASH Clinical Trial

Top Line Results

SUMMARY: IMM-124E Clinical Trial Results

9

• IMM-124E demonstrated good safety and tolerability on both doses

• A statistically significant effect of IMM-124E to reduce serum levels of LPS

• A statistically significant and clinically meaningful effect to reduce ALT levels by 30% or more in patients with elevated ALT at enrollment

• Statistically significant reduction in mean AST compared to placebo.

• Statistically significant effect to reduce CK-18 compared to placebo

• IMM-124E was shown to remain in the gut and not cross into the bloodstream

• No effect on liver steatosis

LPS ANTAGONISM

FIRST IN CLASS MoA

10

NASH

STUDY DESIGN IMM-124E-2001

11

Major Inclusion Criteria

Histologically proven NASH (≤12 months)

• NASH activity score (NAS) ≥4

• Cytologic ballooning score of at least 1

• 10% or more macrovesicular steatosis

• HBA1C of <9.0

SC

RE

EN

ING

≤45 D

IMM-124E 600 mg

IMM-124E 1200 mg

Placebo

FO

LLO

W U

P 4

W

120 patients, 3-arms, Randomized, double

blind, Placebo – 2dose, balanced 1:1:1 design

12

STUDY ENDPOINTS

• Safety

• Hepatic Fat Fraction

PRIMARY

• liver enzymes – ALT, AST, GGT

• Glucose homeostasis and serum lipid profile

• Serum Bovine Ig – Pharmacokinetics

• Establish recommended dose

SECONDARY

• Lipopolysaccharides (LPS)

• CK-18

• Cytokines

• Adiponectin and GLP-1

MoA

STUDY POPULATIONS

13

Patients Screened: N = 237

Patients Randomized: N = 133

Study Analysis Sets:

ITT: 133FAS: 133PP: 102

Screening Failure N = 104

Early Discont.

N = 21

Definitions:

ITT = Intention to Treat

FAS = Full analysis set

PP = Per Protocol

SERUM ALANINE AMINO-TRANSFERASE (ALT)

RATE OF SUBJECTS WITH ≥30% DECREASE *

14

30.3%28.6%

14.3%

0%

5%

10%

15%

20%

25%

30%

35%

IMM 1200mg IMM 600mg PLB* = outlier sites excluded (site recruiting <3 patients) – as commonly practiced in clinical trails

P=0.107

SERUM ALANINE AMINO-TRANSFERASE (ALT)

RATE OF SUBJECTS WITH ≥30% DECREASE*

15

36.4%

27.0%

13.6%

0%

5%

10%

15%

20%

25%

30%

35%

40%

IMM 1200mg IMM 600mg PLB

* ALT BL >50P=0.048

SERUM LIPOPOLYSACCHARIDES (LPS)

RATE OF PATIENTS WITH ≥15% DECREASE*

16

64.3%

59.1%

34.5%

0%

10%

20%

30%

40%

50%

60%

70%


* Baseline LPS>250

P = 0.0184

SERUM LPS

OVERALL RESPONSE TO TREATMENT

TERTILE ANALYSIS

17

• Analysis aimed at

looking at the entire

population

• Shows an overall

beneficial effect across

all patients

• Minimizes risk of cut-off

selection bias

• p=0.0715 (1200mg vs.

PLB)

SERUM CYTOKERATINE-18 (CK-18)

RATE OF PATIENTS WITH ≥15% DECREASE*

18

38.9%

15.2%

18.2%

0%

5%

10%

15%

20%

25%

30%

35%

40%

45%


P = 0.0494

SERUM CK-18

OVERALL RESPONSE TO TREATMENT

TERTILE ANALYSIS

19

• Analysis aimed at

looking at the entire

population

• Shows an overall

beneficial effect across

all patients

• Minimizes risk of cut-off

selection bias

SERUM ASPARTATE-AMINOTRANSFERASE AST

RATE OF SUBJECTS WITH AST DECREASE >30%

20

30.3%

14.3% 14.3%

0%

5%

10%

15%

20%

25%

30%

35%


P=0.107

ASPARTATE TRANSAMINASE (AST)

LINEAR REGRESSION PREDICTED VALUES

21

P=0.0446

HEPATIC FAT FRACTION

22

1200mg 600mg Placebo

Group

-2.5

-2.0

-1.5

-1.0

-0.5

0.0

Ch

an

ge

in

HF

F (

%)

fro

m D

ay

0

LS Mean ± Std Err

• No effect seen in

any of the arms

• Since IMM-124E is

no anti-steatotic

PHARMACOKINETICS

SERUM BOVINE Ig

23

• No significant change in

any of the arm

• All curves remain

essentially flat

Safety Results

24

1200mg IMM124E

n=46 [n(%)]

600mg IMM124E

n=43 [n(%)]

Placebo

n=44 [n(%)]

Total

213192167572

All Adverse Events

5 (10)6 (12)6 (6)28Grade 3-4 subjects (events)

2136SAE1Events

131202Rx stopped due to AE

00141Death

1 SAE - None determined related to study drug

2 Possibly related to study drug: Worsening of Arthraligia - Grade 2

3 Possibly related to study drug: Diarrhea – Grade 1

4 Road accident, Unrelated to study drug

SUMMARY

25

• IMM-124E demonstrates an outstanding safety profile

• IMM-124E shows a significant decrease in serum LPS

making it the first ever LPS-antagonist drug candidate

• IMM-124E reduces Liver enzymes

• IMM-124E demonstrates a significant reduction in CK-18

• No change in Hepatic Fat Fraction was demonstrated in any

study arm

• Pharmacokinetics shows no IMM-124E translocation into

blood

IMM-529

Neutralizing Clostridium difficile, while Sparing the

Microbiome

IMM-529 in Clostridium difficile Infection (CDI)

27

• Biologic with unique triple mechanism of action

- Targets and neutralizes the toxin B, the spores and the vegetative cells

• Potential to redefine the standard-of-care (SOC) therapy for CDI

- Stops virulence, without impacting the microbiome

- Compelling data in all three phases of the disease including (1) prevention of primary

disease, (2) treatment of primary disease and (3) prevention of recurrence

- Orally administrated, safe

• >70% survival rate in CDI mice treated with IMM-529 vs. <7% survival rate

in control groups

• Potential orphan disease designation; Potential breakthrough / fast track

designations

• Market exclusivity (biologics; High barriers to generic biosimilar entry)

IMM-529 for the Treatment of CDI

28

Market

Opportunity

• Therapeutic market is expected to grow from US$356.3 million in 2014 to over $1.5

billion by 2024 – CAGR 15%

• Nearly 30,000 patients die each year from C. difficile infections (US)

• Potential orphan disease (7 years market exclusivity and premium pricing)

Unmet Need

• Vancomycin and metronidazole are the current standard of care, accounting for 80% of

patient share (US)

• However, therapies are plagued by significant CDI recurrences (1st relapse: 25%; 2nd:

40%; 3rd: 50%) underscoring need for new treatments

• There is also growing resistance to vancomycin treatment

IMM-529

Positioning

• Highly differentiated – Neutralizes C. difficile but does not impact microbiome

• Only asset that targets not only toxin B but also the spores and the vegetative cells

responsible for recurrence

• Can be used in combination with standard of care

• Targets many isolates

Sources: GlobalData, Decision Resources, CDC

Triple Action MOA

Neutralizing C. difficile; Sparing the Microbiome

29

Spores – Infectious Particles

IMM-529 antibodies bind to

multiple epitopes on surface

antigens on spores and

prevent adheres to host cells

and limit germination.

Heat, ethanol and UV

resistant. Survive gastric acid,

adhere to cells in the colon

and germinate.

Vegetative Cells


multiple epitopes on the

surface layer proteins (SLP)

on vegetative cells and limit

colonization.

Fimbriae and other surface

layer proteins (SLP) contribute

to bacterial colonization.

Fimbriae are used to adhere to

other bacteria and to host cells

and is one of the primary

mechanisms of virulence

Toxin B


multiple epitopes effectively

neutralize toxin B, inhibiting toxin

mediated epithelial cell apoptosis

and limit toxin translocation into

the systemic circulation and

inflammatory cascades.

Toxin B is essential for

virulence. Toxin B disrupt the

cytoskeleton and tight

junctions of intestinal epithelial

cells.

3

1

2

Results of Pre-Clinical Studies

30

0 .0 0 .5 1 .0 1 .5 2 .0 2 .5 3 .0 3 .5 4 .0

0

2 0

4 0

6 0

8 0

1 0 0

S u r v iv a l

h o u rs p o s t in fe c t io n

Pe

rc

en

t s

urv

iva

l

U n in fe c te d , N o tre a tm e n t

In fe c te d , N o tre a tm e n t

In fe c te d , N o n -im m u n e Ig G tre a tm e n t

In fe c te d , IM M -5 2 9 tre a tm e n t

In fe c te d , V a n c o m y c in tre a tm e n t

Pre

ve

nti

on

Stu

die

s

Demonstrated ~70%

survival rate without

use of antibiotics vs.

0% for control group(P<0.0001)

All studies

statistically

significant

Tre

atm

en

t S

tud

ies

Demonstrated ~80%

survival rate without

use of antibiotics vs.

<7% in control group(P<0.0001)

0 1 2 3 4

0

2 0

4 0

6 0

8 0

1 0 0

D a y s p o s t in fe c tio n

Pe

rc

en

t s

urv

iva

l

S u r v iv a l

In fe c te d , N o tre a tm e n t

In fe c te d , N o n -im m u n e Ig G tre a tm e n t

In fe c te d , IM M -5 2 9 tre a tm e n t

In fe c te d , V a n c o m y c in tre a tm e n t

U n in fe c te d , N o tre a tm e n t

Re

lap

se

Stu

die

s

Demonstrated ~20%

relapse rate vs.

~89% relapse rate in

control group(P<0.0027)

Potentially only

therapeutic

(approved or in

development) that

can treat all

phases of the

disease:

1. Prophylaxis

2. Treatment

3. Recurrence

0 2 4 6 8 1 0 1 2 1 4 1 6 1 8 2 0

0

1 0

2 0

3 0

4 0

5 0

6 0

7 0

8 0

9 0

1 0 0

1 1 0S u r v iv a l

D a y s a fte r v a n c o m y c in tre a tm e n t c e a s e d

Pe

rc

en

t s

urv

iva

l

In fe c te d + S O C

In fe c te d + S O C + IM M -5 2 9**p=0.0027

Phase 1/2 Study Design

31

• Phase 1/2, randomized, double blind, placebo-controlled clinical study of IMM-529

for the treatment of CDI

• 60 subjects to be enrolled up to 3 weeks of definitive diagnosis of CDI (at least 20

subjects to be enrolled within the first 72 hours)

• Subjects randomized to IMM-529 or placebo in a 2:1 ratio

• Treatment duration: 28 days on top of SOC (vancomycin / metronidazole)

• Follow-up: 3 months overall

• Primary objective: To evaluate the safety and tolerability of IMM-529 together with

standard of care (SOC) in patients with CDI

• Secondary objective: To evaluate the effectiveness of IMM-529 together with SOC to

treat patients with CDI

Phase 1/2 Study in CDI Initiated 4Q 2017

NASH and C. difficile Comps Indicate

Potential for Substantial Growth

32

Company Ticker Program Development Stage Market Cap*

Program in NASH

ICPT Obeticholic acid Phase 3 US$2.9B

GNFT Elafibranor Phase 3 US$1.1B

CNAT ENCORE-LF Phase 2 US$195M

Program in C. Difficile

MCRB SER-109; SER-262 Phase 2 US$423M

SMMT SMT19969 Phase 1 US$143M

ASMB ABI-M101 Preclinical US$419M

*As of May 4, 2017

Capital Profile Immuron Limited (ASX:IMC NASDAQ:IMRN)

33

Current Top 10 Shareholders

Current Company

Market CapitalizationAUD$51.2M ≈ USD$39.5M (9th Mar 2018)

Rank Holder Name Current Qty %

1 HSBC CUSTODY NOM AUST LTD (ADR Program) 19,531,706 14.97%

2 * GRANDLODGE PL 9,056,682 6.94%

3 AUTHENTICS AUST PL 8,624,999 6.61%

4 RETZOS EXECUTIVE PL 3,800,000 2.91%

5 * ANASTASIOU PETER + K P 2,907,236 2.23%

6 INVERAREY PL 2,731,632 2.09%

7 * FIFTY-FIFTH LEPRECHAUN PL 2,645,983 2.03%

8 INSYNC INV PL 2,500,000 1.92%

9 SBI INV PR LLC 2,000,000 1.53%

10 ADVANCE PUBLICITY PL 2,000,000 1.53%

TOTAL TOP 20 SHAREHOLDERS 55,798,238 42.76%

BALANCE OF SHARES 74,642,224 57.24%

TOTAL SHARE ON ISSUE 130,440,462 100.00%

* Denotes a Director Related Entity

Key Milestones Expected to Drive Value

34

• IMM-124E

- NASH Phase 2 study

closed

• IMM-529

- Initiation of Phase

1/2 Trial in CDI

• IMM-124E

- NASH Phase 2

topline results

• IMM-124E

- NASH centric

transaction

- Pediatric NAFLD

Phase 2 topline

results

• IMM-124E

- ASH Phase 2 topline

results

• IMM-529

- Topline results expected

from Phase 1/2 study in

CDI

4Q

2017

1Q

20182018 2019

Results from colitis preclinical studies and US

Army and US Navy trials expected 2018

Thank You

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